Kornimate/medical-research-clean huggingface dataset:
a pilot study to determine the impact of clopidogrel (plavix®) on bleeding associated with punch biopsies in healthy volunteers

Conditions: Haemostasis; Healthy

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to determine the feasibility of demonstrating a quantifiable change from baseline in punch biopsy-induced bleeding durations and blood loss volumes in healthy subjects after receiving clopidogrel anti-platelet therapy.


Eligibility criteria:
inclusion criteria: * pt within normal laboratory range exclusion criteria: * the receipt of any investigational drug within 1 month prior to this trial * use of anti-coagulation or anti-platelet therapy-defined as vitamin k antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or nsaids within 30 days prior to trial * african-american race * weight above or equal to 160 kg * recent diagnosis of any illness that would be present concomitant to trial period
patient satisfaction with sedated vs. unsedated colonoscopy

Conditions: Satisfaction

Summary: this is a prospective, observational study to evaluate patient satisfaction with colonoscopy, depending on whether sedation is used during the procedure or not. patients will receive questionnaires before the procedure to assess the potential influence of patient criteria and after the procedure to assess satisfaction-scores and pain-scores. a validated satisfaction score (schoen et al.) will be used for the primary outcome. as secondary parameters, pain- and sedation-scores will be assessed by the validated napcoms score, as well as procedural quality indicators. the study will assess, whether adequate selection in regards to risk factors for sedated or unsedated colonoscopy, leads to similar satisfaction-scores within both groups.

this is a prospective, observational study of consecutive patients presenting for outpatient colonoscopy in a tertiary care hospital with a large ambulatory care section (dkd helios klinik wiesbaden). the primary endpoint of the study is the comparison of a validated patient satisfaction score in patients undergoing colonoscopy with or without sedation. the aim is to assess whether patients, who are deemed appropriate for an unsedated procedure by predefined risk factors and who wish to avoid sedation, will have similar satisfaction scores, as those who undergo sedation. as secondary aims, pain scores (validated napcoms score) and markers of procedural quality (such as completion rates or withdrawal times) will be assessed. considering a 2-point difference in the 15-point satisfaction score as clinically relevant and suspecting a 7:3 distribution of procedures with and without sedation, respectively, 1070 patients must be included (at least 749 sedated and 321 unsedated) in order to reach a significance level of 0.05.

Eligibility criteria:
inclusion criteria: * consecutive patients presenting for colonoscopy * age \>18 years exclusion criteria: * patients not giving written consent * colonic stenosis or suspected stenosis * active inflammatory bowel disease * previous partial resection of the colon * polyposis syndromes * inability to speak german or fill out a questionnaire in german language * vulnerable patients (prisoners, pregnant women, patients with mental retardation, which would affect filling out a questionnaire or answering questions) * american society of anesthesiology (asa) grade \> iii.

Keywords: patient satisfaction unsedated colonoscopy intestinal diseases
intraoperative anuric episodes in patients undergoing laparotomy

Conditions: Intraoperative Anuria

Summary: a single-center prospective observational study. this study examines urine flow and haemodynamic parameters during abdominal surgery and analyses the association to postoperative renal function and markers and to postoperative clinical outcome. primary hypothesis: • within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are phases of temporary anuria. secondary hypothesis: * perioperative anuric phases are directly associated to the postoperative increase of ngal (neutrophil gelatinase-associated lipocalin) and creatinine * perioperative renal dysfunction is directly associated to postoperative complications and functional recovery of patients * a response of urine flow to a standardized postoperative diuretic bolus can identify patients who benefit from a pharmaceutical fluid mobilization * within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the methods for the measurement of stroke volume of the heart differ


Eligibility criteria:
inclusion criteria: * offered patient information and written informed consent * female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour exclusion criteria: * patients with relapse ovarian cancer * patients aged less than 18 years * persons without the capacity to consent * unability of german language use * lacking willingness to save and hand out data within the study * accommodation in an institution due to an official or judicial order * (unclear) history of alcohol or substances disabuse * coworker of the charité * advanced disease of the oesophagus or upper respiratory tract at the beginning of hospitalisation * operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study * neurological or psychiatric disease at the beginning of hospitalisation * chf (congestive heart failure) according to (new york heart association) classification - nyha class iv at the beginning of hospitalisation * american society of anaesthesiologists (asa) classification greater than iv * renal insufficiency (dependency of haemodialysis) at the beginning of hospitalisation * pulmonal oedema in thorax x-ray at the beginning of hospitalisation * history of intracranial hemorrhage within one year before participation in the study * conditions following venous thrombosis within the last three years before study inclusion * known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions * diabetes mellitus with signs of severe neuropathy
phase 1/1b study of tru-016 in patients with previously treated cll or select subtypes of non-hodgkin's lymphoma

Conditions: Chronic Lymphocytic Leukemia (CLL); Non-Hodgkin's Lymphoma (NHL)

Summary: the purpose of this study is to evaluate the safety and tolerability of tru-016 in patients with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical activity in patients with cll and non-hodgkin's lymphoma.

this phase 1/1b open-label study consists of two parts. the initial portion is a phase 1 dose-escalation study evaluating the safety and tolerability of tru-016 administered over a 4-week period to patients with relapsed chronic lymphocytic leukemia (cll). it will identify the mtd and evaluate the pharmacokinetics and immunogenicity of tru-016. upon demonstrating satisfactory safety and tolerability in the phase 1 portion, a phase 1b expansion cohort will be enrolled to further characterize the safety of the selected dose from the first stage of the study and safety and to estimate the clinical activity of tru-016 in patients with treatment-naive cll, relapsed cll and non-hodgkin's lymphoma.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic lymphocytic lymphoma or small lymphocytic lymphoma (phase 1) or relapsed/refractory nhl (phase 1b) * previous treatment with at least one fludarabine-containing regimen * demonstrate at least one of the following criteria for active disease requiring treatment: * a)progressive splenomegaly and/or lymphadenopathy; * b)anemia or thrombocytopenia due to bone marrow involvement; * c)unintentional weight loss \>10% over preceding 6-month period; * d) nci grade 2 or 3 fatigue; * e) fevers \>100.5 f or night sweats for \> 2 weeks without infection; * f) progressive lymphocytosis with increase of \>50% over a 2-month period or anticipated doubling time of \< 6 months. * ecog performance status \</= 2 * sgot, sgpt \</= 2.0 x upper limit of normal * anc \>/= 500/ul * platelets \>/= 30,000/ul * discontinued previous anticancer or investigational therapy for at least 30 days exclusion criteria: * treatment with rituximab within 30 days or alemtuzumab(campath)or radioimmune therapy within 12 weeks * anc \</= 500/ul * platelets \</= 30,000/mm3 * previous or concurrent additional malignancy * significant concurrent medical diseases or conditions * hepatitis b surface antigen or hepatitis b core antibody positive * pregnant or breastfeeding

Keywords: cll nhl tru-016 chronic lymphocytic leukemia non-hodgkin's lymphoma
a prospective natural history study of mucopolysaccharidosis type iiib (mps iiib)

Conditions: Mucopolysaccharidosis Type IIIB

Summary: this is a natural history study for children up to 18 years of age who have been diagnosed with mucopolysaccharidosis type iiib (mps iiib, also known as sanfilippo syndrome type b). mucopolysaccharidosis type iiib is a severe neurodegenerative disorder. the information gathered from this trial may help inform the design and interpretation of subsequent interventional studies. no clinical intervention or study drug is provided by allievex in this study.


Eligibility criteria:
inclusion criteria: * have deficient naglu enzyme activity at baseline. blood for naglu enzyme activity will be collected and analyzed centrally. * is up to 18 years of age * written informed consent from parent or legal guardian and assent from subject, if required * has the ability to comply with protocol requirements, in the opinion of the investigator exclusion criteria: * has another neurological illness that may have caused cognitive decline (e.g., trauma, meningitis, or hemorrhage) before study entry * has received stem cell, gene therapy, or enzyme replacement therapy for mps iiib * has received any investigational medication within 30 days prior to the baseline visit or is scheduled to receive any investigational drug during the course of the study * has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with protocol requirements, the subject's wellbeing or safety, or the interpretability of the subject's clinical data. * is currently participating in another natural history study

Keywords: sanfilippo syndrome type b mps iiib mps 3 b
wear assessment of novel peek telescopic attachment for overdenture

Conditions: Attachment Disorder; Stress Disorder

Summary: to assess the wear of zirconia-peek versus cobalt-chromium-peek telescopic attachments for implant retained complete mandibular overdenture. the wear of zirconia-peek telescopic attachments can affect the retention of implant retained complete mandibular overdenture.

twelve completely edentulous patients were randomly chosen for implant retained telescopic overdentures construction and divided into two groups, where group i was a patient with zirconia copy, and group ii was with cobalt chromium cocr copy. the peek was constructed for both groups as a secondary coping telescopic attachment for the denture. the wear measurements of peek were performed optically by using a usb digital microscope with a built-in camera connected to a compatible personal computer at different intervals of baseline, 3, 6, and 9 months. the data was statistically analyzed and compared using student t-test, anova, and post hoc test.

Eligibility criteria:
inclusion criteria: * completely edentulous * free from any dental or systemic diseases exclusion criteria: * medically ill fit patient * female patient

Keywords: telescopic attachment attachment wear zirconia
evaluation of adhesion quality and irritation of an alternate second generation estradiol transdermal system

Conditions: Healthy

Summary: the primary objective of this study was to compare the adhesive quality of the current mylan estradiol placebo transdermal system, with that of an alternate second generation mylan estradiol placebo transdermal system following a single system application. as a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.


Eligibility criteria:
inclusion criteria: 1. age: 40-66 years. 2. sex: females only. 3. weight: at least 52 kg (115 lbs) and within 20% of ideal body weight (ibw), as referenced by the table of ""desirable weights of adults"" from metropolitan life insurance company, 1999 (see part ii: administrative aspects of human dermal safety study protocols). 4. all subjects should be judged normal and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation and 12-lead ecg) performed within 14 days of the initial patch application. exclusion criteria: 1. institutionalized subjects will not be used. 2. any prior history of skin diseases (eczema, psoriasis, atopic dermatitis). 3. damaged skin in or around test sites that include sunburn, uneven skin tones, tattoos, scars or other disfigurations of the test site. 4. abnormal and clinically significant laboratory test results: 1. clinically significant deviation from the guide to clinically relevant abnormalities (see part ii: administrative aspects of human dermal safety study protocols). 2. abnormal and clinically relevant ecg tracing. 5. subjects who have received an investigational drug within 30 days prior to the initial patch application and/or participated in any transdermal system test for irritation or sensitization within the last 4 weeks. 6. allergy or hypersensitivity to any tapes or adhesives (ex. band-aids, medical tape).
inhaled imatinib pulmonary arterial hypertension clinical trial - follow up long term extension (impahct-ful)

Conditions: Pulmonary Arterial Hypertension

Summary: impahct-ful: inhaled imatinib pulmonary arterial hypertension clinical trial - follow up long term extension (lte) trial was a follow up study to establish the long-term safety of av-101. subjects who successfully completed the 24-week placebo-controlled parent trial (av-101-002, nct#05036135) were offered the opportunity to continue into this lte study. subjects who enrolled in the study were to receive one of three active av-101 doses until such time as the optimal dose was selected in the parent study.


Eligibility criteria:
key inclusion criteria: to be eligible, a participant is required to be or have: * consented to participate in the lte and has successfully completed the placebo-controlled 24-week study av-101-002. key exclusion criteria: subjects meeting any of the following criteria: * the investigator believes that it would not be in the best interest of the subject to be included in the lte e.g., for clinical or social reasons. * subjects who were not compliant with study medication in av-101-002 as assessed by the investigator.

Keywords: pulmonary arterial hypertension lungs pulmonary pah av-101 imatinib impahct impahct-ful
charcot leyden crystals in pathology

Conditions: Asthma

Summary: charcot leyden crystals (clc) are sometime reported in pathological reports of airway or sinonasal samples but their clinical significance remain elusive. the investigators organized a retrospective analysis of all consecutive patients with clc seen at our institution between 1986 and 2019

in recent years, improved knowledge of eosinophilic inflammation has led to the approval of biologics aimed at inhibiting the pathways of eosinophilic activation, notably via the interleukin 5 pathway in eosinophilic asthmatic patients uncontrolled despite receiving maximum doses of standard drugs. these treatments showed efficacy in asthmatic patients with a high level of eosinophils in their induced sputum (\> 3%) and the criteria were extended to those with circulating eosinophilia (\> 300 / mm3). eosinophils are therefore an important biomarker for phenotyping asthmatic patients. the charcot-leyden crystals are a reflection of the presence of eosinophils, and are sometimes found in some pathological samples. it is hypothesized that the presence of charcot-leyden crystals, a reflection of tissue eosinophilia, is a predictive factor for the efficacy of anti-il5 biotherapies in patients with severe eosinophilic asthma.

Eligibility criteria:
inclusion criteria: * having charcot leyden crystals in a pathological sample exclusion criteria: * having charcot leyden crystals in a pathological sample taken outside the airways the nose and the sinus

Keywords: nasal polyposis rhinosinusitis charcot leyden crystals eosinophils
vcrc patient contact registry patient-reported data validation study

Conditions: Behcet's Disease; Churg-Strauss Syndrome; Giant Cell Arteritis; Wegener Granulomatosis; Microscopic Polyangiitis; Polyarteritis Nodosa; Takayasu's Arteritis

Summary: the purpose of this study is to provide validation of patient-reported data in the vcrc patient contact registry by comparing patient-reported data with data provided by the physician who is the primary provider caring for the patient's vasculitis. patients enrolled in the patient contact registry with behcet's disease, eosinophilic granulomatosis with polyangiitis (churg-strauss) (egpa), giant cell arteritis (gca), granulomatosis with polyangiitis (wegener's) (gpa), microscopic polyangiitis (mpa), polyarteritis nodosa (pan), and takayasu's arteritis (tak) were invited via email to participate in this study.

via email, consent was obtained from at least 20 randomly selected patients with the seven forms of vasculitis detailed above in the vcrc patient contact registry who have completed the diagnostic questionnaire. the form was sent in pdf format to the patient, who either printed out or emailed the form to his or her primary vasculitis provider to complete. this form included the same questions in the patient questionnaire, with minor reformatting and a few expanded details to verify the patient-provided data (please see appendix b). if the 20 questionnaires are not returned one month after the initial recruitment email to the patient contact registry participants, 20 additional participants with the seven forms of vasculitis will be selected randomly and will be asked to participate in this study. the survey data is stored by the rare diseases clinical research network's (rdcrn) data management and coordinating center (dmcc) at the university of south florida. the data is de-identified. names or other personal health information were not collected. upon conclusion of the study period, the data will be sent to dr. kathleen mckinnon. all data collected will be sent to the database of genotypes and phenotypes (dbgap) to be stored indefinitely.

Eligibility criteria:
inclusion criteria: * at least 20 patients with each of the following self-identified diagnoses in the vcrc patient contact registry: behçet's disease, egpa, gca, gpa, mpa, pan, and tak who have completed the online questionnaires. exclusion criteria: * inability to provide informed consent and complete survey * patients whose diagnosis of vasculitis was not confirmed by a physician * patients who did not complete the initial questionnaire in its entirety
fastr: fairly brief androgen suppression and stereotactic radiotherapy for high risk prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to examine the safety of a shorter course of radiation treatments combined with one year of androgen deprivation therapy. the study will test this treatment in men with high risk prostate cancer who have significant other illnesses or circumstances such that conventional long term radiotherapy and hormone therapy is not recommended by their physician or desired by the patient.

randomized controlled trials have established the improved efficacy (better biochemical control and disease free survival) of combined radical radiation (70-80gy/7-8 weeks) combined with long term hormone therapy (2-3 years of adjuvant luteinizing hormone releasing hormone (lhrh) agonist) compared to a primary hormone therapy or radiotherapy alone in men with locally advanced/high risk disease. while this approach may be tolerable in fit individuals, this combination may not be well tolerated by frail individuals or those who live at a distance who may find it difficult to attend for 7 weeks of radiation due to travel considerations. those individuals with co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those conditions exacerbated by long term hormone therapy. this pilot study will explore the combination of a stereotactic body radiotherapy (sbrt) approach (designed to be iso-effective for late effects for standard radiotherapy) combined with one year of lhrh agonist for older men with high risk disease who are less fit (vulnerable elderly score \> 3) or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy.

Eligibility criteria:
inclusion criteria: * high risk prostate cancer: * clinical stage t3 (ct3) prostate cancer or * pre-treatment psa \> 20 or * gleason score\>8 on trans-rectal ultrasound (trus) biopsy * score of \> 3 on the vulnerable elderly scale or refuses standard radiotherapy + androgen deprivation therapy * no evidence of extra-prostatic disease on screening bone scan and computed tomography (ct) scan (non-contrast ct used for ct simulation acceptable) * signed written and voluntary informed consent provided. * patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures * age ≥ 18 years exclusion criteria: * patients not meeting the eligibility criteria * prior pelvic radiotherapy or brachytherapy * use of anti-coagulation (low molecular weight heparin or coumadin) * history of inflammatory bowel disease, crohn's disease, diverticulitis or collagen vascular disease (other than rheumatoid arthritis) * previous treatment for malignancy (other than basal or squamous cell skin cancer) within 3 years of prostate cancer diagnosis

Keywords: high risk prostate cancer